Update: The following update relating to this announcement has been issued:

December 20, 2009 -
This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

NOTICE: Applications submitted in
response to this Funding Opportunity Announcement (FOA) for Federal assistance
must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424
(R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application
guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A
registration process is necessary before submission and applicants are highly
encouraged to start the process at least four (4) weeks prior to the grant
submission date. See Section IV.

Purpose. This Funding Opportunity Announcement (FOA), issued by the
National Cancer Institute (NCI), encourages grant applications for research entailing the use of
health claims data for cancer surveillance. Cancer
surveillance may include assessment of patterns of care, quality, and outcomes
of care, and health disparities across the continuum of treatment. The objective of
this FOA is to encourage R03 grant applications from individuals who are
interested in carrying out small research projects that are designed to expand
our understanding of the validity of and methods needed to use claims data for
cancer surveillance. Responses to this FOA may also include pilot analyses needed
to provide preliminary data for larger grant proposals.

Mechanism of Support. This FOA will
utilize the NIH Small Research Grant (R03) award mechanismand runs in parallel with two other FOAs of similar
scientific scope, that encourages applications under
the NIH Exploratory/Developmental (R21) (PA-09-144) and the NIH Research Project
Grant (R01) (PA-09-145) mechanisms.

Funds Available and
Anticipated Number of Awards. Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the size and
duration of each award will also vary. The total amount awarded and the number
of awards will depend upon the mechanism numbers, quality, duration, and costs
of the applications received.

Budget and Project Period. Budgets for direct costs of up to $50,000 per year
and a project duration of up to two years may be
requested for a maximum of $100,000 direct costs over a two-year project
period.

Eligible Project Directors/Principal Investigators (PDs/PIs). Include
Individuals with the skills, knowledge, and resources necessary to
carry out the proposed research are invited to work with their institution/organization
to develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Number of PDs/PIs. More than one PD/PI (i.e., multiple
PDs/PIs), may be designated on the application.

Number of Applications. Applicants
may submit more than one application, provided that each application is
scientifically distinct.

Resubmissions. Applicants may submit a resubmission
application, but such application must include an Introduction addressing the
previous peer review critique (Summary Statement). See new NIH policy on
resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

This Funding Opportunity Announcement
(FOA), issued by the National Cancer Institute (NCI), encourages grant
applications for research entailing the use of health
claims data for cancer surveillance. Cancer surveillance may include assessment
of patterns of care, quality, and outcomes of care, and health disparities
across the continuum of treatment. The objective of
this FOA is to encourage R03 grant applications from individuals who are
interested in carrying out small research projects that are designed to expand
our understanding of the validity of and methods needed to use claims data for
cancer surveillance. Responses to this FOA may also include pilot analyses
needed to provide preliminary data for larger grant proposals.

This FOA will utilize the NIH Small Research Grant (R03)
award mechanismand runs in parallel with two other FOAs of similar
scientific scope, that encourages applications under
the NIH Exploratory/Developmental (R21) (PA-09-144) and the NIH Research Project
Grant (R01) (PA-09-145) mechanisms.

Background

There is increasing interest in the use of secondary data
such as health claims to assess priorities in cancer research as well as cancer
screening, treatment, and outcomes. The 1998 Institute of Medicine report on
Scientific Opportunities and Public Needs: Improving Priority Setting and
Public Input at the NIH (http://www.nap.edu/catalog.php?record_id=6225)
recommends that, "In setting priorities, the NIH should strengthen its
analysis and use of health data, such as on burdens and costs of diseases, and
of data on the impact of research on the health of the public." Increasing
the use of these types of data to assess the quality of cancer care has also
been identified as a priority by the Institute of Medicine (http://www.nap.edu/catalog.php?record_id=9970).
Studies using claims-based data are usually population-based and have the potential
to address a number of priority questions including disparities in health care
based on demographic characteristics and the quality of cancer care. However, the completeness and accuracy of health claims
related to cancer care may vary.

Examples of the types of studies or
hypothesis-generating projects that might be appropriate to this FOA include:

projects that develop innovation statistical methods to
adjust for non-random assignment of patients to treatment in observational data
and analysis of methods for volume-outcomes studies.

projects that include validation of specific services, such as
the ability of health claims to capture a specific treatment or the development
of algorithms to distinguish screening versus diagnostic procedures.

projects that ascertain if health claims have sufficient
numbers of cases to support a specific research question.

The
common characteristic of the small grant is provision of limited funding for a
short period of time. Examples of the types of projects that the NIH supports
with the R03 grant mechanism include, but are not limited to, the
following:

Pilot or feasibility studies

Secondary analysis of existing data

Small, self-contained research projects

Development of
research methodology

Applications for R03 awards should describe projects distinct
from those supported through the traditional R01 and R21 mechanisms. For
example, long-term projects will not be considered for R03 awards. Information
on the NIH R03 small grants be found at http://grants.nih.gov/grants/funding/r03.htm

Related Funding Opportunities: Investigators, who are interested
in proposing
discrete, specified, circumscribed projects based upon strong preliminary data, and exploratory/development
projects, should submit applications in response to the parallel FOAs of
similar scientific scope, which use the R01 grant (PA-09-145)
and the R21 (PA-09-144)
mechanisms.

This FOA will
use the NIH small
grant (R03)award mechanism.The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.

This FOA uses
Just-in-Time information concepts see SF424 (R&R)
Application Guide).It also
uses the modular as well as the non-modular budget formats (seehttp://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, a U.S. organization submitting an application with direct costs
in each year of $250,000 or less (excluding consortium Facilities and
Administrative [F&A] costs) should use the PHS398 Modular Budget component.

All foreign
applicants must complete and submit budget requests using the Research &
Related Budget component.

Because the
nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the NIH Institutes and Centers (ICs)
provide support for this program, awards pursuant to this funding opportunity
are contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications.

A project period of up
to two years and a budget for direct costs of up to two $25,000 modules, or
$50,000 per year, may be requested (i.e., a maximum of $100,000 over two years
in four modules of $25,000 each). Commensurate Facilities and Administrative
(F&A) costs are allowed.

F&A
costs requested by consortium participants are not included in the direct cost
limitation. See NOT-OD-05-004, November 2, 2004.

Any
individual(s) with the skills, knowledge, and resources necessary to carry out
the proposed research as the PD/PI is invited to work with his/her organization
to develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH support.

More
than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application
for projects that require a team science approach and therefore clearly do
not fit the single-PD/PI model. Additional
information on the implementation plans and policies and procedures to formally
allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi.All PDs/PIs must be registered in the NIH electronic
Research Administration (eRA) Commons prior to the
submission of the application (seehttp://era.nih.gov/ElectronicReceipt/preparing.htmfor instructions).

The
decision of whether to apply for a grant with a single PD/PI or multiple
PDs/PIs grant is the responsibility of the investigators and applicant
organizations and should be determined by the scientific goals of the project.
Applications for grants with multiple PDs/PIs will require additional
information, as outlined in the instructions below. When considering
the multiple PD/PI option, please be aware that the structure and governance of
the PD/PI leadership team as well as the knowledge, skills and experience of
the individual PDs/PIs will be factored into the assessment of the overall
scientific merit of the application. Multiple PDs/PIs on a project share the
authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is responsible and accountable
to the grantee organization, or, as appropriate, to a collaborating
organization, for the proper conduct of the project or program, including the
submission of required reports. For further information on multiple PDs/PIs,
please seehttp://grants.nih.gov/grants/multi_pi.

Number of
Applications. Applicants may submit more than one application,
provided that each application is scientifically distinct.

Resubmissions. Applicants may submit
a resubmission application, but such application must include an Introduction
addressing the previous peer review critique (Summary Statement). Beginning with applications intended
for the January 25, 2009 official submission due date (and any other due dates
for FY2010 funding and beyond), all original new applications (i.e., never
submitted) and competing renewal applications will be permitted only a single
amendment (A1). See new NIH policy on resubmission (amended)
applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing
renewal applications that were submitted for due dates prior to January 25,
2009 will be permitted two resubmissions (amendments A1 and A2). For these
grandfathered applications, NIH expects that any A2 will be submitted no
later than January 7, 2011, and NIH will not accept A2 applications after that
date.

Renewals. The R03 is not renewable.

Small grant support may not be used for
thesis or dissertation research.

Section IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for
Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

The
individual(s) designated as PDs/PIs on the application must be registered
also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs
must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.

Each
PD/PI must hold a PD/PI account in the Commons. Applicants should not
share a Commons account for both an Authorized Organization Representative/Signing
Official (AOR/SO) role and a PD/PI role; however, if they have both a
PD/PI role and an Internet Assisted Review (IAR) role, both roles should
exist under one Commons account.

When
multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization
must be affiliated with that organization. PDs/PIs located at another
institution need not be affiliated with the applicant organization, but
must be affiliated with their own organization to be able to access the Commons.

This
registration/affiliation must be done by the AOR/SO or his/her designee
who is already registered in the Commons.

Both
the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps
of the registration process could take four weeks or more. Therefore,
applicants should immediately check with their business official to determine
whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Applicants
must download the SF424 (R&R) application forms and SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms
package directly attached to a specific FOA can be used. You will not be able
to use any other SF424 (R&R) forms (e.g., sample forms, forms from another
FOA), although some of the Attachment files may be useable for more than one
FOA.

Prepare all
applications using the SF424 (R&R) application forms and in accordance with
the SF424 (R&R) Application Guide.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. There are fields within the SF424 (R&R) application components
that, although not marked as mandatory, are required by NIH (e.g., the Credential
log-in field of the Research & Related Senior/Key Person Profile
component must contain the PD/PIs assigned eRA Commons User ID).
Agency-specific instructions for such fields are clearly identified in the
Application Guide. For additional information, see Frequently Asked Questions
Application Guide,Electronic
Submission of Grant Applications.

The
SF424 (R&R) application is comprised of data arranged in separate
components. Some components are required, others are optional. The forms
package associated with this FOA inGrants.gov/APPLYwill include
all applicable components, required and optional. A completed application in
response to this FOA will include the following components:

Proposed research should provide special
opportunities for furthering research programs through the use of unusual
talent, resources, populations, or environmental conditions in other countries
that are not readily available in the United States
(U.S.) or that augment existing U.S. resources.

SPECIAL
INSTRUCTIONS

Applications
with Multiple PDs/PIs

When
multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the
"Contact PI, who will be responsible for all communication between the
PDs/PIs and the NIH, for assembling the application materials outlined below,
and for coordinating progress reports for the project. The contact PD/PI must
meet all eligibility requirements for PD/PI status in the same way as other
PDs/PIs, but has no other special roles or responsibilities within the project
team beyond those mentioned above.

Information
for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover
component. All other PDs/PIs should be listed in the Research &
Related Senior/Key Person component and assigned the project role of
PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included
in the Credential field of the Research & Related Senior/Key Person
component. Failure to include this data field will cause the application
to be rejected.

All projects proposing Multiple PDs/PIs will
be required to include a new section describing the leadership plan approach
for the proposed project.

Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new
section of the research plan, entitled Multiple PD/PI Leadership Plan, must be
included. A rationale for choosing a multiple PD/PI approach should be
described. The governance and organizational structure of the leadership team
and the research project should be described, and should include communication
plans, process for making decisions on scientific direction, and procedures for
resolving conflicts. The roles and administrative, technical, and
scientific responsibilities for the project or program should be delineated for
the PDs/PIs and other collaborators.

If budget allocation
is planned, the distribution of resources to specific components of the project
or the individual PDs/PIs should be delineated in the Leadership Plan. In the
event of an award, the requested allocations may be reflected in a footnote on
the Notice of Award (NoA).

Applications
Involving a Single Institution

When
all PDs/PIs are within a single institution, follow the instructions contained
in the SF424 (R&R) Application Guide.

Applications
Involving Multiple Institutions

When
multiple institutions are involved, one institution must be designated as the
prime institution and funding for the other institution(s) must be requested
via a subcontract to be administered by the prime institution. When submitting
a detailed budget, the prime institution should submit its budget using the
Research & Related Budget component. All other institutions should
have their individual budgets attached separately to the Research & Related
Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R)
Application Guide for further instruction regarding the use of the subaward
budget form.

When
submitting a modular budget, the prime institution completes the PHS398 Modular
Budget component only. Information concerning the consortium/subcontract
budget is provided in the budget justification. Separate budgets for each
consortium/subcontract grantee are not required when using the Modular budget
format. See Section 3.4 of the Application Guide for further instruction
regarding the use of the PHS398 Modular Budget component.

To submit an application in response to
this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow
Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL
NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s)
and time, the application may be delayed in the review process or not reviewed.

Once an application package has been
successfully submitted through Grants.gov, any errors have been addressed, and
the assembled application has been created in the eRA Commons, the PD/PI and the
Authorized Organization Representative/Signing Official (AOR/SO) have two
weekdays (Monday Friday, excluding Federal holidays) to view the application
image to determine if any further action is necessary.

If everything is
acceptable, no further action is necessary. The application
will automatically move forward to the Division of Receipt and Referral in
the Center for Scientific Review for processing after two weekdays,
excluding Federal holidays.

Prior to the submission
deadline, the AOR/SO can Reject the assembled application and submit a
changed/corrected application within the two-day viewing window. This
option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process, the AOR/SO will have the option to Reject the application and
submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to
ensure that the issues are addressed and corrected. Once rejected,
applicants should follow the instructions for correcting errors in Section
2.12, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that
warnings are applicable to your application and need to be addressed now.
Remember, warnings do not stop further application processing. If an
application submission results in warnings (but no errors), it will
automatically move forward after two weekdays if no action is taken. Some
warnings may need to be addressed later in the process.

If
the two day window falls after the submission deadline, the AOR/SO will have
the option to Reject the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or did not
transfer correctly during the submission process). The AOR/SO should first contact
the eRA Commons Helpdesk to
confirm the system error, document the issue, and determine the best course of
action. NIH will not penalize the applicant for an eRA Commons or Grants.gov
system issue.

If
the AOR/SO chooses to Reject the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted but it will be subject to
the NIH
late policy guidelines and may not be accepted. The reason for this delay
should be explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two days.

Upon
receipt, applications will be evaluated for completeness by the Center for
Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from
Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
their application status in the Commons.

The
NIH will not accept any application in response to this FOA that is essentially
the same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. This does not preclude the submission
of an application already reviewed with substantial changes, but such
application must include an Introduction addressing the previous critique.
Note that such an application is considered a "resubmission" for the
SF424 (R&R).

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement.

Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new award if such
costs: 1) are necessary to conduct the project, and 2) would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or award.

The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements and Information

PD/PI
Credential (e.g., Agency Login)

The NIH requires the
PD/PI to fill in his/her Commons User ID in the PROFILE Project
Director/Principal Investigator section, Credential log-in field of the
Research & Related Senior/Key Person Profile component. The applicant
organization must include its DUNS number in its Organization Profile in the
eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For additional information, see Registration
FAQs Important Tips -- Electronic Submission
of Grant Applications.

Organizational DUNS

The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For additional information, see Frequently Asked
Questions Application Guide, Electronic Submission of Grant
Applications.

PHS398 Research Plan Component
Sections

While
each section of the Research Plan needs to be uploaded separately as
a PDF attachment, applicants are encouraged to construct the Research Plan
component as a single document, separating sections into distinct PDF
attachments just before uploading the files. This approach will enable
applicants to better monitor formatting requirements such as page limits. All
attachments must be provided to NIH in PDF format, filenames must be included
with no spaces or special characters, and a .pdf extension must be
used.

All
application instructions outlined in the SF424 (R&R) Application Guide are
to be followed, with the following requirements for R03 applications:

R03 applications will use the modular budget and
non-modular budget format (Foreign organizations) and Just-in-Time
information concepts, with direct costs requested in up to two $25,000
modules, or $50,000 per year, for up to two years (i.e., a maximum of
$100,000 over two years in four modules of $25,000 each). All foreign applicants must complete and submit
budget requests using the Research & Related Budget component.

NIH considers the sharing of unique research resources
developed through NIH-sponsored research an important means to enhance the
value and further the advancement of the research. When resources have been
developed with NIH funds and the associated research findings published or
provided to NIH, it is important that they be made readily available for research
purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing,
this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(b) Sharing
Model Organisms: Regardless of the amount requested, all
applications where the development of model organisms is anticipated are
expectedto include a description of a specific plan for sharing
and distributing unique model organisms and related resources, or state
appropriate reasons why such sharing is restricted or not possible. See Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless
of the amount requested, applicants seeking funding for a genome-wide
association study are expected to provide a plan for submission of GWAS data to
the NIH-designatedGWAS data repository, or provide an
appropriate explanation why submission to the repository is not possible.
A genome-wide association study is defined as any study of genetic variation
across the entire genome that is designed to identify genetic associations with
observable traits (e.g., blood pressure or weight) or the presence or absence
of a disease or condition. For further information see Policy for Sharing
of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies
(go to NOT-OD-07-088,
and http://grants.nih.gov/grants/gwas/.)

Foreign
Applications (Non-domestic [non-U.S.] Entities)

Indicate how the proposed project has specific
relevance to the mission and objectives of the NIH/IC and has the potential for
significantly advancing the health sciences in the United States

Section V. Application Review
Information

1. Criteria

Only the review
criteria described below will be considered in the review process.

2.
Review and Selection Process

Applications submitted for this
funding opportunity will be assigned on the basis of established PHS referral
guidelines to the ICs for funding consideration.

Applications
that are complete will be evaluated for scientific and technical merit by an
appropriate scientific review group(s) in accordance
with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

Applications
submitted in response to this funding opportunity will compete for available
funds with all other recommended applications. The following will be
considered in making funding decisions:

Scientific
and technical merit of the proposed project as determined by scientific
peer review.

Availability
of funds.

Relevance
of the proposed project to program priorities.

The NIH R03
small grant is a mechanism for supporting discrete, well-defined projects that
realistically can be completed in two years and that require limited levels of
funding. Because the Research Strategy is restricted to 6 pages, a
small grant application will not have the same level of detail or extensive
discussion found in an R01 application. Accordingly, reviewers should evaluate
the conceptual framework and general approach to the problem, placing less
emphasis on methodological details and certain indicators traditionally used in
evaluating the scientific merit of R01 applications, including supportive
preliminary data. Appropriate justification for the proposed work can be
provided through literature citations, data from other sources, or from
investigator-generated data. Preliminary data are not required, particularly in
applications proposing pilot or feasibility studies.

The mission of the NIH is to support science in pursuit
of knowledge about the biology and behavior of living systems and to apply that
knowledge to extend healthy life and reduce the burdens of illness and
disability. As part of this mission, applications submitted to the NIH
for grants or cooperative agreements to support biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to
exert a sustained, powerful influence on the research field(s) involved, in
consideration of the following five core review criteria, and additional review
criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of
the five review criteria below in the determination of scientific and technical
merit, and give a separate score for each. An application does not need
to be strong in all categories to be judged likely to have major scientific
impact. For example, a project that by its nature is not innovative may
be essential to advance a field.

Significance. Does the project address an
important problem or a critical barrier to progress in the field? If the
aims of the project are achieved, how will scientific knowledge, technical
capability, and/or clinical practice be improved? How will successful
completion of the aims change the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and
other researchers well suited to the project? If Early Stage
Investigators or New Investigators, do they have appropriate experience and
training? If established, have they demonstrated an ongoing record of
accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation. Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies,
instrumentation, or interventions novel to one field of research or novel in a
broad sense? Is a refinement, improvement, or new application of
theoretical concepts, approaches or methodologies, instrumentation, or
interventions proposed?

Approach. Are the overall strategy, methodology,
and analyses well-reasoned and appropriate to accomplish the specific aims of
the project? Are potential problems, alternative strategies, and
benchmarks for success presented? If the project is in the early
stages of development, will the strategy establish feasibility and will
particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) Protections for Human Subjectss, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in
which the work will be done contribute to the probability of success? Are
the institutional support, equipment and other physical resources available to
the investigators adequate for the project proposed? Will the project
benefit from unique features of the scientific environment, subject
populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project
proposed, reviewers will consider the following additional items in the
determination of scientific and technical merit, but will not give separate
scores for these items.

Protections for Human Subjects. For
research that involves human subjects but does not involve one of the six
categories of research that are exempt under 45 CFR Part 46, the committee will
evaluate the justification for involvement of human subjects and the proposed
protections from research risk relating to their participation according to the
following five review criteria: 1) risk to subjects, 2) adequacy of protection
against risks, 3) potential benefits to the subjects and others, 4) importance
of the knowledge to be gained, and 5) data and safety monitoring for clinical
trials.

For research that involves human subjects and meets
the criteria for one or more of the six categories of research that are exempt
under 45 CFR Part 46, the committee will evaluate: 1) the justification for the
exemption, 2) human subjects involvement and characteristics, and 3) sources of
materials.

Inclusion of Women, Minorities, and Children.
When the proposed project involves clinical research, the committee will
evaluate the proposed plans for inclusion of minorities and members of both
genders, as well as the inclusion of children.

Vertebrate Animals. The committee
will evaluate the involvement of live vertebrate animals as part of the
scientific assessment according to the following five points: 1) proposed use of
the animals, and species, strains, ages, sex, and numbers to be used; 2)
justifications for the use of animals and for the appropriateness of the species
and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting
discomfort, distress, pain and injury to that which is unavoidable in the
conduct of scientifically sound research including the use of analgesic,
anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and
5) methods of euthanasia and reason for selection if not consistent with the
AVMA Guidelines on Euthanasia.

Resubmission Applications. When
reviewing a Resubmission application (formerly called an amended application),
the committee will evaluate the application as now presented, taking into
consideration the responses to comments from the previous scientific review
group and changes made to the project.

Renewal Applications. When reviewing
a Renewal application (formerly called a competing continuation application),
the committee will consider the progress made in the last funding period.

Revision Applications. When
reviewing a Revision application (formerly called a competing supplement
application), the committee will consider the appropriateness of the proposed
expansion of the scope of the project. If the Revision application relates to a
specific line of investigation presented in the original application that was
not recommended for approval by the committee, then the committee will consider
whether the responses to comments from the previous scientific review group are
adequate and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess
whether materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Additional Review Considerations

As applicable for the project
proposed, reviewers will address each of the following items, but will not give
scores for these items and should not consider them in providing an overall impact/priority score.

Budget and Period Support. Reviewers will consider whether
the budget and the requested period of support are fully justified and
reasonable in relation to the proposed research.

Select Agents Research. Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications from Foreign
Organizations. Reviewers will assess whether the project presents special opportunities for
furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions that exist in other countries and
either are not readily available in the United States or augment existing U.S. resources.

A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee business
official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section IV.5.,
Funding Restrictions.

A final progress report, invention statement,
and Financial Status Report are required when an award is relinquished when a
recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Human Subjects
Protection:Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing
Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).Investigators should
seek guidance from their institutions, on issues related to institutional
policies and local institutional review board (IRB) rules, as well as local,
State and Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the data sharing plan but will not factor the plan into the
determination of the scientific merit or the impact/priority score.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women, Minorities, and Children:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs
in NIH Grant Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and
Regulations:This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review
requirements of Executive Order 12372. Awards are
made under the authorization of Sections 301 and 405 of the Public Health
Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42
CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Loan
Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.